Gan & Lee Insulin Glargine Target Type (2) Evaluating Research
| Status: | Recruiting | 
|---|---|
| Conditions: | Diabetes, Diabetes | 
| Therapuetic Areas: | Endocrinology | 
| Healthy: | No | 
| Age Range: | 18 - 75 | 
| Updated: | 5/20/2018 | 
| Start Date: | October 20, 2017 | 
| End Date: | January 31, 2020 | 
| Contact: | Gan & Lee Pharmaceuticals, USA | 
| Email: | ClinicalTrials@GanLee.US | 
| Phone: | 8442185504 | 
AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE III STUDY TO COMPARE THE IMMUNOGENICITY, EFFICACY, AND SAFETY OF GAN & LEE PHARMACEUTICALS INSULIN GLARGINE INJECTION TO LANTUS® IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Primary Objective:
• To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of
immunogenicity
Secondary Objective:
• Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin
antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26
			• To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of
immunogenicity
Secondary Objective:
• Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin
antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26
Inclusion Criteria:
- Type 2 Diabetes
We found this trial at
    57
    sites
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									1720 2nd Ave S
Birmingham, Alabama 35233
	
			Birmingham, Alabama 35233
(205) 934-4011  
							 
					Phone: 205-934-4112
					
		University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...  
  
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									500 Chase Parkway
Waterbury, Connecticut 06708
	
			Waterbury, Connecticut 06708
203-419-4420
					Phone: 203-419-4404
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									1969 W Ogden Ave
Chicago, Illinois 60612
	
			Chicago, Illinois 60612
(312) 864-6000
							 
					Phone: 312-864-0537
					
		John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...  
  
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									34509 9th Avenue South
Federal Way, Washington 98003
	
			
					Federal Way, Washington 98003
Phone: 253.927.7256
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									5017 Green Bay Road
Kenosha, Wisconsin 53144
	
			
					Kenosha, Wisconsin 53144
Phone: 262-925-1282
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									18531 Roscoe Boulevard
Northridge, California 91324
	
			
					Northridge, California 91324
Phone: 818-349-1979
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									1031 Office Park Road
West Des Moines, Iowa 50265
	
			
					West Des Moines, Iowa 50265
Phone: 515-329-6800
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